Progesterone replacement with vaginal gel versus i.m. injection: cycle and pregnancy outcomes in IVF patients receiving vitrified blastocysts

Abstract

STUDY QUESTIONDoes the type of luteal support affect pregnancy outcomes in recipients of vitrified blastocysts?SUMMARY ANSWERLuteal support with vaginal progesterone gel or i.m. progesterone (IMP) results in comparable implantation and pregnancy rates in IVF patients receiving vitrified blastocysts.WHAT IS KNOWN ALREADYIn fresh IVF cycles, both IMP and vaginal progesterone have become the standard of care for luteal phase support. Due to conflicting data in replacement cycles, IMP is often considered to be the standard of care.STUDY DESIGN, SIZE, DURATIONRetrospective analysis of 920 frozen embryo transfer (FET) cycles between 1 January 2010 and 1 September 2012.PARTICIPANTS/MATERIALS, SETTING, METHODSPatients from a large, private practice undergoing autologous and donor FET using IMP or vaginal progesterone gel for luteal support were included in the analysis. IMP was used for luteal support in 682 FET cycles and vaginal progesterone gel was used in 238 FET cycles. Standard clinical outcomes of positive serum hCG levels, implantation, clinical pregnancy, spontaneous abortion and live birth were reported.MAIN RESULTS AND THE ROLE OF CHANCEThe IMP and vaginal progesterone gel groups had similar patient demographics for all characteristics assessed. Implantation rates (46.4 versus 45.6%, P = 0.81), clinical pregnancy rates (61.7 versus 60.5%, P = 0.80) and live birth rates (49.1 versus 48.9%, P > 0.99) were not significantly different between IMP and vaginal progesterone gel, respectively.LIMITATIONS, REASONS FOR CAUTIONThis study is limited by its retrospective design and by its lack of randomization to the type of luteal support. In addition, because no a priori expected rates of success could be provided for this retrospective investigation, it was not possible to estimate statistical power associated with the various outcomes presented.WIDER IMPLICATIONS OF THE FINDINGSWith the recent trends toward single embryo transfer (SET) and use of vitrified blastocysts in FET cycles, our data with ∼40% of cycles being SET and use of exclusively vitrified blastocysts are more relevant to current practices than previous studies.STUDY FUNDING/COMPETING INTEREST(S)Support for data collection and analysis was provided by Actavis, Inc. D.S. has received honoraria for lectures and participation in Scientific Advisory Boards for Actavis, Inc. J.P. is an employee of Actavis, Inc. N.E. has received payment from Actavis, Inc., for her time for data collection. H.H. has received payment from Actavis, Inc., for statistical analyses. Z.P.N. has nothing to disclose.

Serum progesterone levels greater than 20 ng/dl on day of embryo transfer are associated with lower live birth and higher pregnancy loss rates

“…Currently, there are three different routes of administration of exogenous P4; vaginal, intramuscular, and oral [5,6]. When compared to human chorionic gonadotropin (HCG), the use of P4 luteal support is preferable to the use of HCG because it performs better in FET cycles [7] and has a lower chance of ovarian hyperstimulation syndrome [5].…”

Preparation of endometrium for frozen embryo replacement cycles: a systematic review and meta-analysis

“…Although there is substantial evidence that intramuscular and vaginal routes have comparable ongoing pregnancy/live birth rates [67] in fresh autologous cycles, there is controversy in FER cycles. In FER cycles, some studies reported better pregnancy outcome with intramuscular route [68,69], whereas the majority of the studies reported similar pregnancy outcome [70][71][72].…”

Mid-luteal serum progesterone concentrations govern implantation rates for cryopreserved embryo transfers conducted under hormone replacement

“…Consequently, several clinical groups view vaginal administration of progesterone as superior to other routes (Ho et al, 2008;Manno et al, 2005;Tavaniotou et al, 2000). Conversely, a recent investigation has demonstrated that vaginal gel and intramuscular injection of progesterone showed comparable implantation and pregnancy rates in IVF patients receiving vitrified blastocysts (Shapiro et al, 2014). Therefore, we are not aware of any utero-vaginal portal venous system that might enable a true first pass effect for progesterone, nor do we believe that vaginal pessaries saturate the pelvic tissues to any significant degree for direct absorption.…”